MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for ETHICON ETH5BB manufactured by Sterilmed, Inc..
[109535577]
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. No device was received for analysis at the time of submission of the initial 3500a. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.? Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109535578]
It was reported that a patient underwent a procedure with an endopath. The babcock was placed on fallopian tube by the doctor. He pressed the button to lock it. Dr. Pressed to release it and the button broke off. The babcock was locked on the fallopian tube. A hemostat was used to release the babcock from fallopian tube. There was no damage to fallopian tube continued with procedure without any further complications. There were no patient consequences. Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available. The ethicon endopath's inability to open while on the patient was assessed as a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00101 |
| MDR Report Key | 7541693 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-04-26 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ETHICON |
| Generic Name | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2018-05-24 |
| Returned To Mfg | 2018-06-25 |
| Model Number | ETH5BB |
| Catalog Number | ETH5BB |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-24 |